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

Model Number SC-1160

Device Problems High impedance (1291); Mechanical Problem (1384); Use of Device Problem (1670); Migration (4003)

Patient Problems Inadequate Pain Relief (2388); No Code Available (3191)

Event Date 06/25/2019

Event Type  Injury  

Event Description

A report was received that the patient underwent an ipg replacement procedure due to high impedances caused by open ipg ports that could not be closed.The patient is doing well post operatively.

Manufacturer Narrative

Additional information was received that one lead was also replaced.An x ray confirmed the lead migrated as the ipg ports were not fully functioning causing high impedances.The patient only experienced stimulation on one side and in the rib area.The lead was replaced due to physician preference.Additional suspect medical device components involved in the event: product family: scs-linear leads upn: m365sc2317700 model: sc-2317-70 serial: (b)(4) batch: 5074306 product family: scs-linear leads upn: m365sc2317700 model: sc-2317-70 serial: (b)(4) batch: 7026652 the lead was not returned to bsn.The returned ipg was analyzed and the complaint of high impedance readings were not confirmed.The ipg was tested with known good leads.Impedance values were normal when checked using a test remote control.A borescope inspection on the ipg header found no anomalies.The ipg setscrew anomaly has been confirmed.All setscrews were filled with silicone debris from the septa which caused the hex wrench to not engage with the screws.The center portion of the septum got damaged when the setscrew is loosened until it touches the septum opening.Once the silicone pieces were removed, the set screws were loosened using a hex wrench and screwed back into place in the lab.The damage is considered procedure-related.

Event Description

A report was received that the patient underwent an ipg replacement procedure due to high impedances caused by open ipg ports that could not be closed.The patient is doing well post operatively.

Event Description

A report was received that the patient underwent an ipg replacement procedure due to high impedances caused by open ipg ports that could not be closed.The patient is doing well post operatively.

Manufacturer Narrative

Additional information was received that one lead was also replaced due to lead migration as the ipg ports were not fully functioning.The lead was replaced due to physician preference and will not be returned to bsn.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 5074306; product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 7026652.

Event Description

A report was received that the patient underwent an ipg replacement procedure due to high impedances caused by open ipg ports that could not be closed.The patient is doing well post operatively.

Manufacturer Narrative

Should have stated- additional information was received that one lead was also replaced.An x ray confirmed the lead migrated as the ipg ports were not fully functioning.The patient only experienced stimulation on one side and in the rib area.The lead was replaced due to physician preference.Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(4).Batch: 5074306.Product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(4).Batch: 7026652.The returned ipg was analyzed and the complaint of high impedance readings were not confirmed.The ipg was tested with known good leads.Impedance values were normal when checked using a test remote control.A borescope inspection on the ipg header found no anomalies.The setscrew anomaly has been confirmed.All setscrews were filled with silicone debris from the septa which caused the hex wrench to not engage with the screws.The center portion of the septum got damaged when the setscrew is loosened until it touches the septum opening.Once the silicone pieces were removed, the set screws were loosened using a hex wrench and screwed back into place in the lab.The damage is considered procedure-related.

• Brand Name: SPECTRA WAVEWRITER
• 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: 8778149
• MDR Text Key: 150624529
• Report Number: 3006630150-2019-03437
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 342098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 09/09/2019; 09/17/2019
• Supplement Dates FDA Received: 07/24/2019; 09/12/2019; 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention