MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR

Model Number SC-1132

Device Problems Telemetry Discrepancy (1629); Issue With Displayed Error Message (2967); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2017

Event Type  malfunction  

Event Description

A report was received that the patient was having difficulty connecting ipg and was receiving an error message.It was identified that the problem was with the patient¿s ipg.Database analysis showed signs of data corruption.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the physician suspected device malfunction.

Event Description

A report was received that the patient was having difficulty connecting ipg and was receiving an error message.It was identified that the problem was with the patient¿s ipg.Database analysis showed signs of data corruption.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure.The patient was doing well postoperatively.Sc-1132 (sn (b)(4)) device evaluation indicated that the reported error ((b)(4)) is translated to writing a slot to flash failed.Although the error condition was not repeated during the failure investigation using an asus (s/n (b)(4)), it found that system data log (battery profile data) was corrupted.Unused portion of the data was set to binary 1 ((b)(4)) on which the current data is being written over, and the device functioned normally.The source of the data anomaly was not known.

Event Description

A report was received that the patient was having difficulty connecting ipg and was receiving an error message.It was identified that the problem was with the patient¿s ipg.Database analysis showed signs of data corruption.The patient will undergo an ipg replacement procedure.

• Brand Name: PRECISION SPECTRA
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6775373
• MDR Text Key: 82121881
• Report Number: 3006630150-2017-02929
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2019
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR