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

Model Number SC-1110-02

Device Problems Premature Discharge of Battery (1057); Device Inoperable (1663)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm.

Event Description

A report was received that the patients scs was non-functional.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that no further information could be obtained.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 med watch will be filed.

Event Description

A report was received that the patients scs was non-functional.The patient will undergo an explant procedure.

Event Description

A report was received that the patient's scs was non-functional.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted device was not returned to bsn as it was kept by the medical facility.

Manufacturer Narrative

Correction to the follow-up mdr #2 in field d7.

Event Description

A report was received that the patients scs was non functional.The patient will undergo an explant procedure.

• 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: 7555386
• MDR Text Key: 109622931
• Report Number: 3006630150-2018-01936
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• 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,Followup,Followup
• Report Date: 03/18/2020

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: Lay User/Patient
• Device Expiration Date: 04/01/2013
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 14250684
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 01/28/2020; 02/25/2020
• Supplement Dates FDA Received: 07/11/2018; 02/17/2020; 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR