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

Model Number SC-1110

Device Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631); Device Inoperable (1663)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2138-50 serial #: (b)(4).Description: scs 50cm iii lead the explanted devices were not returned to bsn.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

A report was received that the patients ipg was non-functional and was not giving pain relief.The patient underwent an ipg and lead explant procedure.Device malfunction was suspected.

Manufacturer Narrative

Correction to initial mdr in age field.

Event Description

A report was received that the patients ipg was non-functional and was not giving pain relief.The patient underwent an ipg and lead explant procedure.Device malfunction was suspected.

• 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: 7545333
• MDR Text Key: 109308673
• Report Number: 3006630150-2018-01825
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2008
• Device Model Number: SC-1110
• Device Catalogue Number: SC-1110
• Device Lot Number: 171342
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR