MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-9208-15

Device Problems Failure to Charge (1085); High impedance (1291)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect devices reference number: 11372593, product family: scs-adapters, upn: (b)(4), model: sc-9208-15, serial: (b)(4), batch: 7028062.Reference number: 11422378, product family: scs-ipg-r, upn: (b)(4), model: sc-1160, serial: (b)(4), batch: 350414.Implant date of two sc-9208-15 is unknown; implant date of sc-1160 is (b)(6) 2019.

Event Description

A report was received that the patient was implanted with a competitors lead and a bsn ipg and lead adaptor.A surgery was performed to convert the patient to newer technology and after doing so impedances were good on all contacts.During post operative programming, multiple high impedances were noted.The patient was brought back into the operating room as an emergency and the battery site was opened again.The leads were straightened out and a new adaptor was tried however the impedance problem did not resolve.The leads were then connected directly to the ipg and once again there was no change.The physician examined the tails of the competitors lead and believed there was some discoloration and air bubbles.He assessed that as the lead had been in a certain position for six years when they straightened it out a microscopic tear occurred allowing fluid to get under the silicone causing an impedance buildup.They were unable to resolve this issue so the physician chose to close the patient and perform another surgery the following week to replace the lead.During that week the ipg was connected and was fully charged.This was left insitu for the week connected to the bsn lead adaptor.No programming was performed.The following week the patient underwent the surgery and the competitors lead and bsn adaptors were removed and replaced with a bsn lead.It was noted at that time that the ipg was completely flat with no charge and therefore the ipg was also replaced.

Manufacturer Narrative

Additional suspect devices product family: scs-adapters upn: m365sc9208150 model: sc-9208-15 serial: (b)(4) batch: 7028062 product family: scs-ipg-r upn: m365sc11600 model: sc-1160 serial: (b)(4) batch: 350414 field d6 implant date clarification implant date of two sc-9208-15 is (b)(6) 2019.Implant date of sc-1160 is (b)(6) 2019.

Event Description

A report was received that the patient was implanted with a competitors lead and a bsn ipg and lead adaptor.A surgery was performed to convert the patient to newer technology and after doing so impedances were good on all contacts.During post operative programming multiple high impedances were noted.The patient was brought back into the operating room as an emergency and the battery site was opened again.The leads were straightened out and a new adaptor was tried however the impedance problem did not resolve.The leads were then connected directly to the ipg and once again there was no change.The physician examined the tails of the competitors lead and believed there was some discoloration and air bubbles.He assessed that as the lead had been in a certain position for six years when they straightened it out a microscopic tear occurred allowing fluid to get under the silicone causing an impedance buildup.They were unable to resolve this issue so the physician chose to close the patient and perform another surgery the following week to replace the lead.During that week the ipg was connected and was fully charged.This was left insitu for the week connected to the bsn lead adaptor.No programming was performed.The following week the patient underwent the surgery and the competitors lead and bsn adaptors were removed and replaced with a bsn lead.It was noted at that time that the ipg was completely flat with no charge and therefore the ipg was also replaced.

Manufacturer Narrative

Model sc-9208-15, serial numbers (b)(4).The two returned adaptors were analyzed.The complaint of 13 contacts were out even when connecting the associated leads directly to the ipg was not verified.Visual x-ray inspections and continuity check found no anomalies.Model sc-1160, serial number (b)(4).It was reported that after the implant procedure the ipg was completely flat with no charge.The ipg was analyzed and the complaint was confirmed.The device would not be charged after three charging attempts.It also would not power up using an external power source.It exhibited excessive sleep current and high thermal on u2 asic and low vh high voltage impedance.This type of damage occurs when the ipg is exposed to high-voltage transients based on the direction for use.It was confirmed that electrocautery was used during the implant procedure.

Event Description

A report was received that the patient was implanted with a competitors lead and a bsn ipg and lead adaptor.A surgery was performed to convert the patient to newer technology and after doing so impedances were good on all contacts.During post operative programming multiple high impedances were noted.The patient was brought back into the operating room as an emergency and the battery site was opened again.The leads were straightened out and a new adaptor was tried however the impedance problem did not resolve.The leads were then connected directly to the ipg and once again there was no change.The physician examined the tails of the competitors lead and believed there was some discoloration and air bubbles.He assessed that as the lead had been in a certain position for six years when they straightened it out a microscopic tear occurred allowing fluid to get under the silicone causing an impedance buildup.They were unable to resolve this issue so the physician chose to close the patient and perform another surgery the following week to replace the lead.During that week the ipg was connected and was fully charged.This was left insitu for the week connected to the bsn lead adaptor.No programming was performed.The following week the patient underwent the surgery and the competitors lead and bsn adaptors were removed and replaced with a bsn lead.It was noted at that time that the ipg was completely flat with no charge and therefore the ipg was also replaced.

• Brand Name: PRECISION
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8946444
• MDR Text Key: 156404646
• Report Number: 3006630150-2019-04659
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729893271
• UDI-Public: 08714729893271
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2020
• Device Model Number: SC-9208-15
• Device Catalogue Number: SC-9208-15
• Device Lot Number: 7028939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention