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

Model Number SC-1132

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that patient's ipg had migrated.It was also noted that the charger will not stop beeping when placed over implant.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg was not returned.

Manufacturer Narrative

Sc-1132 (sn (b)(6)).The returned ipg was analyzed, passed the functional test, and an electrical test revealed normal device characteristics.The reported event was not confirmed as reported observation with testing of the product return.Hence, the probable cause selected for this complaint is no problem detected.

Event Description

It was reported that patients ipg had migrated.It was also noted that the charger will not stop beeping when placed over implant.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg was not returned.

• Brand Name: PRECISION SPECTRA
• 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: 10267653
• MDR Text Key: 198618233
• Report Number: 3006630150-2020-02888
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2019
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 202015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR